ICH

The International Conference on Harmonisation (ICH) is a multilateral undertaking involving the leading drug regulatory authorities and pharmaceutical trade groups in the world. Now in its third decade, the ICH has streamlined the regulatory assessment process for new drug applications by creating global validation criteria.

ICH is the standards organization credited with developing eCTD

By standardizing submission procedures, the ICH allows health professionals to focus on science and medicine instead of a cumbersome regulatory process. As a result, consumers enjoy faster access to life-saving treatments and an implicit guarantee of safety, efficacy, and quality.

To date, the crowning achievement of the ICH is the Electronic Common Technical Document (eCTD). The eCTD is a single, technical dossier, submitted through an electronic gateway, or another form of media. Its implementation is rendering voluminous, paper submissions obsolete. The eCTD facilitates simultaneous submission to multiple regions, shorter approval timelines and the acceleration of new drugs to market. Specifications for the eCTD were defined by the ICH M2 Expert Working Group, and such specifications provide the ability to transfer the registration application electronically from industry to regulatory authority.

The eCTD format has also made it easier to develop standardized review tools for each review discipline. Europe, Japan, and the US FDA prefer eCTD submissions – and according to Thomson Reuters – at least 40 regulatory agencies now accept eCTD submissions.

Important ICH Documents

eCTD v4.0 Step 4 Implementation Package, April 6, 2016
ICH M8 Specification for Submission Formats for eCTD, April 6, 2016